Cleared Traditional

K910836 - LIMA COLLARED CL STEM

K910836 is an FDA 510(k) clearance for LIMA COLLARED CL STEM, manufactured by Lima Intl. Corp.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K910836 · Lima Intl. Corp. · Orthopedic device
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Jun 1991
Decision
107d
Days
Class 2
Risk

K910836 is an FDA 510(k) clearance for the LIMA COLLARED CL STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Lima Intl. Corp. (Miami Beach, US). The FDA issued a Cleared decision on June 14, 1991 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Lima Intl. Corp. devices

FDA 510(k) Submission Details - K910836

510(k) Number K910836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1991
Decision Date June 14, 1991
Days to Decision 107 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 526
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K910836.
FUTURA FEMORAL HIP STEM
K910093 · O'Tec Corp. · Jul 1991
BIOMET COBALT-CHROME FEMORAL COMPONENTS
K911684 · Biomet, Inc. · Jun 1991
NEXUS(TM) FEMORAL HIP STEM
K911052 · Dow Corning Wright · Jun 1991
BIOPRO METAL BACKED CEMENTED ACETABULAR CUP
K910352 · Biopro, Inc. · Jun 1991
HOWMEDICA(R) CEMETED FEMORAL COMPONENT
K910869 · Howmedica Corp. · May 1991
S-ROM OBLONG ACETABULAR CUP
K905258 · Joint Medical Products Corp. · May 1991